Quality Systems Manager

**Careers that Change Lives**
BELLCO, now part of Medtronic in the Renal Care business, is a company, based in Mirandola (Modena - ITALY), leader in systems for hemodialysis and extracorporeal blood purification. Our therapies and systems are employed for the treatment of renal failure, multiple organ failure, sepsis and cardiac decompensation. We are focused on satisfying the needs of patients and experts through: Innovation, Research, Development of advanced Nephrology, Intensive Care and Cardiology Therapies.

We are searching for Quality System Manager

**A Day in the Life**
- Define, implement and maintain and improve Quality System requirements in the form of Quality Assurance
- Supervise personnel within an area of the Quality Operations Department. Take the lead in this area.
- Develop and modify Procedures and other related procedures
- Participate/support the Management Review Process
- Provide reports/information to management on quality related issues and define and implement solutions to quality related issues
- Participate in and lead cross-functional teams as directed by the Sr. Quality Manager
- Participate in and lead internal/external audits as required
- Ensure that product conforms to specification and control further processing, delivery on installation or non-conforming product until the deficiency or unsatisfactory condition has been corrected
- Ensure that preventive and corrective actions are taken in relation to product and Quality system deficiencies and initiate, recommend or provide solutions to product and Quality system related problems
- Drive Quality Improvement and Quality Excellence Programs
- Interface with other departments to ensure that Quality system requirements are adhered to
- Participate in and initiate job-related training courses
- Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities in order to improve the workplace for all employees

**Must Have: Minimum Requirements**
- Master’s degree qualified (Engineering or Scientific study) with at least 10 years’ experience in a manufacturing organization
- Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry
- Knowledge of FDA, MDSAP and ISO compliance
- Must be capable of carrying out documentation related responsibilities as well as technical responsibilities
- Ability to work well as part of team and also to lead a team
- Strong communication, organizational and project planning skills.
- Ability to write engineering documents, test protocols, FMEAs
- Skilled in statistical methods (Hypothesis testing, SPC, sampling plans, Gage R&R, process capability and graphical analysis).
- Able to analyze and chart data using MS Excel or Minitab.

**Nice to Have**
- Medical Device/Healthcare Industry experience is desirable
- Experience in Design Quality is desirable.
- Previous Quality Auditor experience is desirable or certification is an advantage

**About Medtronic**

Bold thinking. Bolder actions. We are Medtronic.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are **engineering the extraordinary **.

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